MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM NERVE BLOCK TRAY

Catalog Number 570245

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported tray catalog number or involved tegaderm material number.If a physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports there have been 4 to 5 patients reacting to the tegaderm dressing in the kit.Adductor canal peripheral nerve block catheters were performed for total knee replacements.All the patients expressed sensitivities to the dressing at the same areas in the upper legs.Onset was noted within a couple days of application.The symptoms of sensitivities are under the large tegaderm dressing (6 inch x 8 inch) with severe skin irritation, red inflamed macular papillary, blisters, redness, and/or tenderness.No respiratory sensitivities, distress, or intervention needed.One patient was intravenously treated with benadryl & steroids for blisters.The remaining patients were assessed by surgeons and were reassured that symptoms would go away without any treatment.

• Brand Name: CUSTOM NERVE BLOCK TRAY
• Type of Device: NERVE BLOCK TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5377644
• MDR Text Key: 36338081
• Report Number: 2523676-2015-00696
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 570245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other